| (a) License fee. Except as provided by §229.245
of this subchapter (relating to Exemption), no person may operate
or conduct business as a wholesale distributor of nonprescription
drugs without first obtaining a license from the department. All applicants
for an initial wholesale distributor of nonprescription drugs license
or a renewal license must pay a licensing fee unless otherwise exempt
as provided by subsection (c) of this section. All fees are nonrefundable.
Licenses are issued for two-year terms. A license shall only be issued
when all past due administrative penalties, license fees, and delinquency
fees are paid.
(1) In-state wholesale distributors of nonprescription
drugs who are not manufacturers must pay a two-year license fee based
on the gross annual sales of all nonprescription drugs.
(A) For a wholesale distributor with gross annual nonprescription
drug sales of $0 - $199,999.99, the fees are:
(i) $1,040 for a two-year license;
(ii) $1,040 for a two-year license issued due to a
change of ownership; and
(iii) $520 for a license issued during the current
licensure period due to minor changes.
(B) For a wholesale distributor with gross annual nonprescription
drug sales of $200,000 - $19,999,999.99, the fees are:
(i) $1,690 for a two-year license;
(ii) $1,690 for a two-year license issued due to a
change of ownership; and
(iii) $845 for a license issued during the current
licensure period due to minor changes.
(C) For a wholesale distributor with gross annual nonprescription
drug sales greater than or equal to $20 million, the fees are:
(i) $2,210 for a two-year license;
(ii) $2,210 for a two-year license issued due to a
change of ownership; and
(iii) $1,105 for a license issued during the current
licensure period due to minor changes.
(2) In-state wholesale distributors of nonprescription
drugs who are not manufacturers and who also are required to be licensed
as a device distributor under §229.439(a) of this chapter (relating
to Licensure Fees) or as a wholesale food distributor under §229.182(a)(3)
of this chapter (relating to Licensing/Registration Fee and Procedures)
must pay a combined two-year license fee for each place of business.
License fees are based on the combined gross annual sales of these
regulated products (foods, drugs, and devices).
(A) For each place of business having combined gross
annual sales of $0 - $199,999.99, the fees are:
(i) $520 for a two-year license;
(ii) $520 for a two-year license issued due to a change
of ownership; and
(iii) $260 for a license amended during the current
licensure period due to minor changes.
(B) For each place of business having combined gross
annual sales of $200,000 - $499,999.99, the fees are:
(i) $780 for a two-year license;
(ii) $780 for a two-year license issued due to a change
of ownership; and
(iii) $390 for a license amended during the current
licensure period due to minor changes.
(C) For each place of business having combined gross
annual sales of $500,000 - $999,999.99, the fees are:
(i) $1,040 for a two-year license;
(ii) $1,040 for a two-year license issued due to a
change of ownership; and
(iii) $520 for a license amended during the current
licensure period due to minor changes.
(D) For each place of business having combined gross
annual sales of $1 million - $9,999,999.99, the fees are:
(i) $1,300 for a two-year license;
(ii) $1,300 for a two-year license issued due to a
change of ownership; and
(iii) $650 for a license amended during the current
licensure period due to minor changes.
(E) For each place of business having combined gross
annual sales greater than or equal to $10 million, the fees are:
(i) $1,950 for a two-year license;
(ii) $1,950 for a two-year license issued due to a
change of ownership; and
(iii) $975 for a license amended during the current
licensure period due to minor changes.
(3) In-state wholesale distributors of nonprescription
drugs who are manufacturers must pay a two-year license fee based
on the gross annual sales of all nonprescription drugs.
(A) For a wholesale distributor with gross annual nonprescription
drug sales of $0 - $199,999.99, the fees are:
(i) $1,040 for a two-year license;
(ii) $1,040 for a two-year license issued due to a
change of ownership; and
(iii) $520 for a license amended during the current
licensure period due to minor changes.
(B) For a wholesale distributor with gross annual nonprescription
drug sales of $200,000 - $1,999,999.99, the fees are:
(i) $1,235 for a two-year license;
(ii) $1,235 for a two-year license issued due to a
change of ownership; and
(iii) $620 for a license amended during the current
licensure period due to minor changes.
(C) For a wholesale distributor with gross annual nonprescription
drug sales of $2 million to $9,999,999.99, the fees are:
(i) $1,560 for a two-year license;
(ii) $1,560 for a two-year license issued due to a
change of ownership; and
(iii) $780 for a license amended during the current
licensure period due to minor changes.
(D) For a wholesale distributor with gross annual nonprescription
drug sales of $10 million to $19,999,999.99, the fees are:
(i) $1,885 for a two-year license;
(ii) $1,885 for a two-year license issued due to a
change of ownership; and
(iii) $940 for a license amended during the current
licensure period due to minor changes.
(E) For a wholesale distributor with gross annual nonprescription
drug sales greater than or equal to $20 million, the fees are:
(i) $2,210 for a two-year license;
(ii) $2,210 for a two-year license issued due to a
change of ownership; and
(iii) $1,105 for a license amended during the current
licensure period due to minor changes.
(4) Out-of-state wholesale distributors of nonprescription
drugs must pay a two-year license fee based on all gross annual sales
of nonprescription drugs delivered into Texas.
(A) For each wholesale distributor with gross annual
nonprescription drug sales of $0 - $19,999,999.99, the fees are:
(i) $1,300 for a two-year license;
(ii) $1,300 for a two-year license issued due to a
change of ownership; and
(iii) $650 for a license amended during the current
licensure period due to minor changes.
(B) For each wholesale distributor with gross annual
nonprescription drug sales of greater than or equal to $20 million,
the fees are:
(i) $1,950 for a two-year license;
(ii) $1,950 for a two-year license issued due to a
change of ownership; and
(iii) $975 for a license amended during the current
licensure period due to minor changes.
(b) Proration of license fees. A person having more
than one place of business may request a one-time proration of the
license fees when applying for a license for each new place of business.
Upon approval by the department, the license for the new place of
business will have a renewal date the same as the firm's other licensed
places of business.
(c) Exemption from license fees. A person is exempt
from the license fees required by this section if the person is a
charitable organization, as described in the Internal Revenue Code
of 1986, 26 USC §501(c)(3), or a nonprofit affiliate of the organization,
to the extent otherwise permitted by law.
|
